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Using DNA methylome screening to improve live birth rates in IVF

Whether Using DNA Methylome to Select Embryos Can Increase the Live Birth Rate During Assisted Reproductive Technology: A Multicenter, Randomized , Open-label Clinical Trial.

Not applicable Interventional Shandong University · NCT05442125

This study is testing if using DNA screening to choose embryos can help women undergoing IVF have more successful pregnancies compared to the usual methods.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1146 (estimated)
Ages20 Years and up
SexFemale
SponsorShandong University Academic / other
Locations28 sites (Jinan, Shandong and 27 other locations)
Trial IDNCT05442125 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether selecting embryos based on DNA methylome screening can enhance live birth rates compared to conventional in-vitro fertilization methods. The research focuses on the role of DNA methylation in embryogenesis and its potential as a biomarker for selecting viable embryos. Women undergoing IVF treatment who have good-quality blastocysts will be randomly assigned to either the DNA methylome screening group or the conventional morphologic scoring group. The goal is to validate the effectiveness of Pre-implantation Methylome Screening (PIMS) in improving outcomes in assisted reproductive technology.

Who should consider this trial

Good fit: Ideal candidates are women aged 20 years and older who are planning to undergo IVF and have at least two good-quality blastocysts.

Not a fit: Patients with uterine abnormalities or those using donated gametes are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the chances of live births for women undergoing IVF.

How similar studies have performed: While the use of DNA methylome screening is a novel approach, previous studies have suggested that similar methodologies may improve embryo selection outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Women who plan to undergo IVF/ICSI/PGT-A treatment.
2. Women aged 20 years and older.

b) Women who obtain 2 or more good-quality blastocysts that defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.

Exclusion Criteria:

4.2 Exclusion Criteria

1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus unicornate, bicornate, or duplex); untreated uterine septum, submucous myoma, or endometrial polyp(s); or with history of intrauterine adhesions.
2. Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
3. Women who use donated oocytes or sperm to achieve pregnancy;
4. Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.

Where this trial is running

Jinan, Shandong and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Reproductive Techniques, AssistedDNA Methylation
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.